Aromatherapy as Treatment Nausea: A Randomized Trial Ronald Hunt, MD,* Jacqueline Dienemann, PhD, RN,+ H. for Postoperative James Norton, PhD, + Wendy Hartley, MSN, RN,§ ‘Amanda Hudgens, BSN, RNj|| Thomas Stern, MD, {| and George Divine, PhD# BACKGROUND: Postoperative nausea (PON) Is @ common complication of anesthesia and surgery. Antiemetic medication for highersisk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be Feduced signifcantly by aromatherapy with (1) essential ol of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, of (3) Isopropy! alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used METHODS: A rancomizes ‘trial of aromatherepy with patients who reported nausea In the postanesthesia care unit was conducted at one ambulatory surgical center. Elighilty criteria ‘were adult, able to give consent, and no histoy of coagulation problems or allergy to the ‘aromatherapy agents. Before surgery, demographic and risk factors were collected, Patients with ‘a nausea level of 1 to 3 on a verbal descriptive scale (0-3) recelved a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (03) \was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were glven as ordered by physicians or as requested by the patient. RESULTS: A total of 1152 subjects were screene’ for Inclusion; 303 subjects reporting nausea ‘were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant forthe blend (P < 0.001) and ginger (P = 0.002) versus saline but not for alcohol (P < 0.76). The number of antiemetic medications requested after aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P< 0.001, resnectivey) CONCLUSION: The hypothesis that aromatherapy would be effective as a treatment for PON was ‘supported. On the basis of our results, future research further evaluating aromatherapy Is warranted, Aromatherepy is promising as an inexpensive, noninvasive treatment for PON that can bbe administered and controlled by patients as needed. (Anesth Analg 2012;X:eee-ee) cently, nonpharmaceutical therapies have been evaluated for use in the treatment of postoperative nausea (PON).! Aromatherapy is appealing for use in PON because its noninvasive administration allows use by either medical staff or patients, and its low cost offers ‘greater accessibility to patients. However, to this point, it thas been unknown which, if any, aromas or combinations of aromas are actually effective in reducing PON; thus, for ‘purposes of this study, we hypothesized simply that aro- rmatherapy will reduce PON. ‘The aromas chosen for inclusion in this study were selected on the basis of traditional applications advocated bby aromatherapists for the treatment of nausea, From te “Department of Anesthesia, Cras Medial Center Chorio, NC Seo! ot Nursing Univer of North Carita Chat [Charli NC Department of Bt, Carolinas Mca Cer, Cu Tote, NC: Sina Cae Managemen, Carolus Medial Cee, chai, NC Carl Medial Caner Univer, Curie NCS {epee ot ce Caraias Mecca Cater Unwerst, Carte NC PDE Held Scena Heny Ford Hepa Det Ml cep for pulinton December 21, 2001 Feeding: None The authors dane no cont of interest Reprints will at be vale fom the authors lence to Ronald Hunt, MD, Caztinse Medical Cener 'No"Tryon, Charts NC 29262 ‘Addres eal (Copyright © 2012 iteration Anesthesia Resench Sodety YOK 2012 * Volume X « Number X ‘A randomized trial design was used to examine the use ‘of aromatherapy in comparison with the action ofa placebo for treating PON. The primary endpoint for assessment ‘was change in PON nausea score 5 minutes after aroma- therapy administration. METHODS ‘This study was a prospective 4arm placebo-controlled lnical trial to examine reduction in severity of nausea using aromatherapy with essential oil of ginger, an essen- tial oll blend of ginger, spearmint, peppermint, and carda- mom, or 70% isopropyl alcohol in comparison with the ‘change in nausea severity with the use of the placebo, normal saline. The measure of nausea was a verbal, de- sctiptive {point scale (VDS) from 0 to 3 with zero being none, 1 being some, 2 being @ lot, and 3 being severe? This scale was chosen from other global scales of severity for tease of administration and because patients were recover- ing from anesthesia, Minor changes were made in the formatting of the scale for its use in the study. In the original scale, the anchor points were labeled 0 = no nausea, 1 = mild, 2 + moderate, 3 = severe; and these labels were changed for use in this study to 0 = none, 1 = some, 2= a lot, and 3 = severe. IRB approval was obtained from Carolinas Health System and the University of North Carolina at Charlotte. The trial was not registered with clinicaltrials gov. Al participants were from 1 ambulatory surgical site in the Charlotte metropolitan area and were contacted on the wwwanesthesicnaigesiaog 1 ‘Copyright © 2042 International Anesthesia Research Society. Unauthorized reproduction of this article is prohibited.“Rromatherapy for Postoperative Nausea day of their surgery. Trained research nurses recruited subjects who met eligibility criteria of being age 18 years or ‘older, being cognitively abe to give informed consent, having surgery that day, not receiving warfarin (Coumadin) heparin, full dose 325 mg aspirin, or clopidogrel (Plavn), and not having a history or diagnosis of bleeding diatheses or any nove allergies to ginger, spearmint, peppermint or carda- mom. The exclusion of patients with clotting disorders was based on studies finding antiplatelet and. cyclooxygenase-1 enzymes inhibitors from constitutions of ginger.” ‘Written informed consent was obtained from ll patients, After consent, participants were asked to provide demo- ‘graphic information about their ender, age, and race/ethnic heritage, and were screened for PON risk factors including history of smoking, motion sickness (car ea), and PON. ‘Any determination to premedicate participants was atthe sole discretion of their physicians, as this study was con- ducted in a natural setting, The study tools completed by the research nurses included information of any preoperative antiemetic medications. Each tol ane a study participant tag, ‘were placed in the medical record to follow the participant from Surgery tothe postanesthesiacare unit (PACU). ‘Treatment instruments Aromatherapies used were normal saline, 70% isopropy! alcohol, essential oil of ginger, and a blend of the essential oils of ginger, spearmint, peppermint, and cardamom. One cubic centimeter of the randomly selected, designated aromatherapy was placed on a 2-inch by 2-inch imperme- able, backed gauze pad. Each aromatherapy was stored in 2 plain white bottle labeled 1 to 4 and Kept in a locked cart labeled “For Research Purposes Only.” Despite the lack of any identifying label, the study treatment arms could not be blinded because of the specificity of odors. This research used the method of assessment and administration re- ported by Anderson and Gross* Procedure ‘ter surgery, esearch nurses coleted the following dat: time surgery began and ended, tows oxide or volte gas tnesthesia, type of surgery, and. administation of any intraoperative aiemetic medications. Partipans were asked fo rate ter level of nausea using the VBS on 2 010 3ikertaype scale of ~ no nae, 1 = sme, 2 = at, nd 3 = sree Those who reported zero or no nausea Were not assigned toa testment group, Fartcipants who responded witha score of 109 were randomly assigned to 1 of the 4 treatment groupe using a computerized isting for random tscignments generated by Assumption College” The Te search nase checked ofthe study namber of the pari pant and aromatherapy onthe list and then prepated the Tac partcipant was insted to inhale the scent rough the nose aden through the mouth 3 mes At the end of Simi, each subject was ake to ate the evel of nausea again sing the VDS, and the aromatherapy was discotin- tes. Ie nagen wos rated 1 to 3 at the end of 3 mines, participants were ofered anemecs ax prescribed by th Theanpton Caloge nian agent © gouge Hetil fo ‘amin /snodon apes Randaig/ Grp. 2 wwwwanesthesic-ancigesiaorg physicians. If vomiting occurred, the number of times was ‘documented and antiemetic medication given. ‘A protocol deviation occurred in 2 of the 303 partic- [pants who reported PON. These 2 subjects were excluded. from the protocol analysis because of what was believed to bbe a degradation of the blend of the aromatherapy oils. ‘These subjects, both of whom had been randomized to the blend, complained that the aroma was not “pleasant” so the research team investigated and found that the aroma of the blend had changed. Its hypothesized that degradation ‘occurred. because of either an oxidation reaction during. repeated usage of the blend and the lid not being secured tightly or failure to shake the bottle before each use, which ‘may have allowed for layering of the oils with the lightest ‘il on top being used completely and the heaviest oils zemaining behind. The study was suspended until an appropriate solution to this problem could be found. "To address the oxidation/evaporation concerns, we changed the bottle size from 10 ce to 5 cc to limit the amount of degradation due to air. In addition, the research nurses were instructed to secure the lid after each use and ‘were educated as tothe need to thoroughly shake the bottle before each use to prevent the layering of the oils. The protocol was then restarted. On the basis of the above, the total number of participants in the blended oll group differs by 2 subjects between the per-protocol (PP) and intent-o- ‘reat (ITT) analyses. Ifa patient in the treatment group received antiemetic ‘medication while in the PACU, that fact was recorded. The administration of an opioid in the PACU was also docu- ‘mented. No additional data were collected. Sample Size The target sample size for the study was computed on the basis of a Wilcoxon ranked-sum test comparing 1 of the 3 active treatment arms to the normal saline control group. Fora Wilcoxon ranked-sum test the effect being tested may be expressed as p” = Prob(X < ¥), where X and Y are representative subjecs from the control and active arms, respectively. Under the null hypothesis, p'” = 05. It was assumed that p” = 0.63 would present a clinically impor tant effect, and using a formula given by Noether,* a sample size of 7 per group was computed. The impact of ties is not incorporated in Noether’s formula, but their ‘presence will increase posver, so the final target sample size was fixed at 75 subjects per group (or 300 total). There were reports inthe literature suggesting that each ofthe 3 active treatments might be of benefit) therefore a multiple- comparison adjustment was not incorporated inthe original sample size calculation. However, a a result of suggestions received during the manuscript review proces, a Bonferroni adjustment for the 3 primary comparisons is now included in ‘the main analyses. The impact ofthis change is described in an updated and more detailed sample size presentation given inva companion paper appearing inthis issue of Anestisia & Analgesia Data Analysis ‘To describe the treatment groups at baseline, we calculated descriptive statistics including means, standard deviations, ANESTHESIA & ANALGESIA Copyright © 2012 International Anesthesia Research Society. Unauthorized reproduction ofthis article is prohibitedcounts, and percentages. Demographic and baseline vari- ables were compared among the 4 groups. Age was the only variable on an interval scale, so analysis of variance (ANOVA) was used for age. A Kruskal-Wallis test was "used to test for an association between group and the mean ‘number of emesis episodes before/during surgery. The significance of associations between potential nominal scale risk factors and nausea was assessed using a x* or Fisher exact test For the principal outcome variable, change in level of ‘nausea using the VDS, Wilcoxon rank sum exact (permu- tation) test P values were used to compare the groups 2 at a time. For each Wilcoxon test, the observed probability of 2 patient in one arm having @ greater decrease in nausea ‘VDS than a patient in another arm [p"” = Prob(X < Y)] was computed along with 2.95% confidence interval (or 98.3%, 3f Bonferroni adjusted). To assist in interpretation, each value, and its corresponding confidence limits, was con- verted to the odds of seeing a bigger improvement [ie odds = p'"/(1 ~ p")]. Finaly, the proportions of patients ‘with any improvement in VDS and requesting antinausea ‘medication were computed and compared between arms. For each outcome, a Bonferroni adjustment was made for the 3 primary comparisons to the saline control group. ‘The other 3 pairwise comparisons (among alcohol, singe, and blend) were considered secondary and were made without any multiple-comperisons adjustment, because a significant difference for one or more ofthese comparisons would not be definitive without there also being least 1 significant difference versus saline (contro) RESULTS, ‘A total of 1190 patients were screened for inclusion to partic ‘ate in the study. Four consented but vomited on enty to the PACU and were exchided; I subject was dropped at physician request due to high blood. pressure in the PACU; and 3 subjects withdrew requesting antiemetic medications before aromatherapy. The data from 31 subjects were excluded as incomplete resulting ina sample of 1151 subjects. Aer a total sample size of >300 had been accrued, encollment in the study was ended. Seven risk factors were significant predic- {ors of nausea for this sample: history of motion sickness or PON, surgery over 60 minutes, volatile gas anesthesia, opiods ater’ surgery, female gender, gynecological surgery, and gastrointestinal surgery Of the 1151 participants, 301 (262%) reporting PON and receiving the intended aromatherapy agent were included. in the PP analysis. Eighty-nine of the 301 reporting nausea received antiemetic medication before (n = 49) or during (ie = 40) surgery. The PP sample included 73 patients receiving normal saline, 78 receiving 70% isopropyl alco- hol, 76 receiving essential ol of ginger, and 74 receiving the blend of essential oils of ginger, spearmint, peppermint, and cardamom, There were no significant diferences in the ‘demographic characteristics, significant visk factors, or in receiving. pre- or intraoperative antiemetic medication among the groups (Table 1). There was no significant difference in the intially reported nausea severity level among the 4 different aromatherapy groups (P ~ 0.951) (Table 2). One hundred eighty-seven participants re- 200 2012 + Volume X + Number X ‘Ginger Blend 73) (m= 78) (n= 76) (n= 74) Prake 4.3 403-425 «408 0.70" @ 70" 7, gk, Oe a 0 ak i ioele za zy os7 Table 2. Significant Predictors of Nausea, Receiving of Antiemetic Medication Before, re en ee sy Cou habe) ‘Ginger end ‘outcomes’ (= 73) (n= 78) (m= 76) (n= 78) Pralue Fomaie © 7 mm 8 086 Histoy maton 380393933 BA ‘sickness HetoyPON 409 DO Wolatiegss/ 70 7O.S73sT_—(O Leransumey 40 3788 ‘over 60 Sismey 828 Gyecsoges 52 TO ‘unger, Posoperave 4652 AT BOB Popmfectc 1st rmodeaton Timesemesis 0270220210803" (mean) ‘PON = postoperative naves; Gr= gesvontestnat. "Plu rm Krk Wail et ‘quested antiemetic medication after aromatherapy, with 115 (61.5%) coming from the placebo and alcohol groups. “The reels ofthe tial are summarized in Figures 12, and and in Tables 3,4, and 5. As can be sen from Figure 1, al 4 groups had shifts toward reduced nausea, with the ginger and blend groups having the biggest shifts. The primary hypothesis tet results are found in the first column of Table 3 in which the Bonferron-adjusted Wilcoxon ranked-sum test P values for ginger versus saline and for blend versus saline are P= 002 and P < 0.00, respectively. In secondary compar- sons among the 3 acive ams, ginger and blend were also superior fo alcohel (P = 0017 and P = 0.001). The strengths of the differences among treatment arms are reflected in the ‘odds found in Table 3. For instance, the odds of having a {greater reduction in PON score with ginger versus saline are almost 2 to 1 (186), and for blend versus saline, the odds approach 3 to 1 270). The odds of greater reduction with singer and blend versus alcohol are also fairly large, 150 and. 213, respectively. There was lite evidence that aleohol was helpful The odds ofa greater reduction with alcohol versus saline were only 12, and the Bonferron-adjusted P value for this comparison was 076. wow.anesinesio-onaigesiacig 3 Copyright @ 2012 Intemational Anesthesia Research Society. Unauthorized reproduction of this article is prohibited.Figure 2. Change In postoperative nausea (PON) «| Ginger cf Mec or aemoborey ose = 2 i | Ea ee ‘Number of Patients 5 Change in PON Score a Pecan Pats Parent of Pans 8 8 o- y ° ' Seine Aeabel Ginger Ban Seine Ache Giger ond roe coup Figure 2. Percentage of patients reporting any Improvement by Figure 3. Percentage of patients requesting antinzusea medication ‘rematherapy gu. by aromatherapy group. 4 wwwanesthesic-cnoigesia.org ANESTHESIA & ANALGESIA Copyright © 2012 international Anesthesia Research Society. Unauthorized reproduction ofthis article is prohibited.eos Y) and Associated Odds of Better Improvement in Nausea Relief Between-Arms Comparisons (Confidence Intervals) and Significance Levels (P Values) — ‘r(amm < Saino) Oads (95% Ci) Alcon 0.55 1.22(0.82, 1.88) (Po0-76) Singer 0.85 1.86 1.22, 300) 20.002) lena 0.732.70 (4.78, 456) (20.001), PHAM < Aloho}) Odes (95% Cl) PA(Arm < Alcohol) Odds (98% C1) 0.60 1.50 (1.08, 213) (0.087) 0.68 2.15 (1.80, 3.17) (P<0.001), 0.58 1.38 (0.96, 1.98) (P-0.07) ihe “eon ve anihe™ cohin how 96.5% covidance arts (Cl (oarespondrg wo Sunfaron austen fr these wma compare). The seconde onparca clans (am vs eal and amv pg have 3% contdence ces. Contdence mera omsued areng wen SAS PROC LOGS 6 ‘Selene to the Cina), Pvatuesearaed wth SAS PROC NPARAWAY ‘Table 4. Comparisons of Arm Estimates of Any Improvement (Yes/No) in Nausea Relief by Aroma Between-Arms Comparisons (Confidence Intervals) and F Values ‘Ae ve slot "Amn vs singer 15.8 (0.5, 31.1)(P0.05) ‘Am Armspecite estimate (and Cl) ‘Arm vs saline Sale 39.7% 285, 51.9) ‘coho! 51.36 (39.7, 62.8) 11.6 (7.7, 30.8) (60.33) Ginger 67.1% (65.4, 77.5) 27.4 6, 46. (0.002) Biene 82.4% (71.8, 9.3) 42,7 25.4, 60.0) (P<0.001) BL 217.4, 45.2) P<0.001) 15.3 (1.7, 29.0) (P=0.03) The “ew saine” colin han 98.3% condense eral (Gi (eonespondeg to Gana! austen! fr the inary earparaarak: The sesndery ‘hmparaon eam om ve seal and sms ge ave arence sale Ce ison of Arm Estimates and Percentage Patients Requested Antinausea Medication (Yes/ RO Meerut ‘Arm Armspecite Estimate (CD) ‘am ve aeohel ‘am vs ginger Saline 20.8% (69.9, 89.1) Acomol 71.8% (60.5, 81.4) -9.0 25.5, 7.4)(P=0.58) Gregor 55.3% (43.4,66.7) -25.6(~43.1, -B.0)(P=0.002) | ~16.5 (~31.5, -1.5) Berd 40.8%(29.3,526) _—40.3(-578,-22.7)(P=<0001) ~31.3(-46.3, 10.3) 7147-306, 1.1)(P=007) ‘he “arm ve sane” colin has GEN cancence leas (3) lorespardig to Bonforon| eden for ese pry compavaona: The szandary orparon eam (um Ws schol and sm we gn Hee condone anal ‘The treatment effects reflected by the proportions of patients reporting any improvement (Table 4 and Fig. 2) or requesting antinausea medication (Table 5 and Fig. 3) are also large and consistent with Table 3 and Figure 1. For all 3 outcomes, ginger and blend were both superior to either saline or alcohol. There is also a suggestion in the data that blend may be better than ginger alone. The odds of having ‘a greater reduction in PON score with blend versus ginger are 138. The P value for this and for the comparison of the proportions requesting antinausea medication was P = 10.07, but the P value for the proportion with any improve- ment as a dichotomous outcome was 0.03, The ITT analysis population differed only for the blend ‘group, and the ITT blend comparisons were virtually identical to those forthe PP analysis for saline and alcohol (P < 0.001 {for all 3 outcomes). For blend versus ginger, the ITT results ‘were slightly less favorable to blend, with estimates of the ‘cxlds of lower PON score with blend decreasing to 130 from, 138 (P = 0113). The any improvement outcome was no longer significant (P = 0.07) and the P value for antinausea medica- tion requested increased slightly to 0.11, DISCUSSION ‘This study found aromatherapy using oil of ginger or a bend of ginger, spearmint, peppermint, and cardamom to be an effective treatment in reducing nausea severity ‘occurring after surgery in an acute care setting. Aroma- therapy also reduced the number of requests for antiemetic ‘medication due to PON. PON is a common complication after surgery,?~ and its root cause is unknown. Ifa patient is at high risk for PON 300 2012 « Volume X + Number due to uncontrollable factors, the guidelines recommend using antiemetic medicines as prophylaxis for PON. There is no consensus as to the optimal antiemetic therapy." Nonpharmaceutical therapies offer important altematives to antiemetic therapies with their benefits including but not limited to their low cost and the noninvasive nature oftheir administration. Among the nonpharmaceutical therapies available forthe treatment PON are aromatherapy treatments, ‘We hypothesized that aromatherapy might be beneficial in reducing PON and designed this study to evaluate 3 different aromatherapies in comparison with a placebo t test this hypothesis. However, because there was no consen- sus inthe Scientific literature atthe time ofthis study as to ‘what aromas or combinations of aromas actually might be fective in reducing PON, this study may be viewed as an objective, data-based frst look at this important adjunct to ‘current antinausea therapies. The results ofthe study strongly suggest that while more research is needed to better under- stand its efficacy over time, aromatherapy as a fast-acting agent either alone or combined with antiemetic medications ‘merits additional research inthe treatment of nausea. ‘Aromatherapy using alcohol as a treatment has been. shown to be significantly more effective than, or to have the ‘same effectiveness as, antiemetic medication in 4 random- ized controlled trials (RCT) with small samples.” It was also found fo reduce nausea significantly faster in 2 RCTs **” but concems were raised about the duration of effect”; because of modest sample sizes and differences in design, there was insufficient evidence for a recommen- dation. Results of 2 RCTs of aromatherapy using waw.onesthesa-analgesiaorg 5 Copyright © 2042 international Anesthesia Research Society. Unauthorized reproduction ofthis article is prohibited.‘Aromatherapy for Postoperative Nausea ‘peppermint oil as a treatment were significant, but again the samples were very small, ‘One study used antiemetic medications with and with- out aromatherapy with oil of ginger™ and found a 50% reduction in nausea withthe ginger aromatherapy, but the {import of the finding is unclear because no sample size or description of the nausea measure was given. Seven RCTS studying the ingestion of ginger powder as a preventive measure for PON show mixed results"*** Ginger is not mentioned in the 2010 PON rescue recommendations. How- ever, the Western Australia Centre for Evidence Informed Healthcare Practice review of prevention and treatment of PON for abdominal laparoscopic~ gynecological procedures? found “some limited evidence to support providing ginger in doses between 1 to 5g to prevent or reduce PON and to reduce the need for rescue medication” (p. 20). Unfortunately, the calculation of 3 meta-analyses yielded conflicting conclusions, with 2 finding ginger ineffective and 1 finding it effective as a preventive measure for PON, ‘Only 2 studies of aromatherapy with a blend of oils for ‘treatment elated to PON were found, with neither using a control group. One used the essential oils of ginger, pep- permint, spearmint, and lavender sold in an inhaler and 39 of 46 participants (85%) reported nausea relief over 24 hours” Another study used an aromatherapy blend of ginger, cardamom, and tarragon in equal parts applied to the anterolateral aspect of the neck with 56 of 76 partic- pants (74%)™ reporting relief of nausea Tn a study of physician practice using vignettes, 6% reported that they would use alcohol aromatherapy for PON.” Memorial Sloan Kettering Cancer Center reports reviewing the evidence and offering aromatherapy with alcohol, ginger, and peppermint as treatments for PON.** ‘This study has several limitations including the follow- ing: (1) limiting the aromatherapy to a 5-minute interval and not testing its efficacy over a longer period: @2) not controlling for the type of antiemetic given pre- or intraop- eratively; (8) not having a large enough sample to explore the differential effects with patients who did or did not receive premedication to prevent nausea or different risk factor combinations; (4) uncertainty about the causes ofthe aromatherapy blend degradation and protocol deviation; (6) not having a large enough sample size to detect differ. ‘ences in rates of emesis for different aromatherapies versus placebo; and (6) use ofa rating scale for assessing levels of nausea in the subjects that is a variation of a previously validated instrument. The research design for this study was limited to inves- tigating whether certain aroma treatments reduce the se- verity of postsurgery nausea, Boogaerts eta.” showed 86% agreement between a 10-point visual analog scale and a ‘point VDS with the points defined as 0 = no nausea, 1 = mild, 2 ~ moderate, and 3 ~ severe. The 4-point scale used in this study followed that order very closely by using 1 Fiewit Hy Wate R. The efletvness of noninvasive complementary tories in adingpotoperstverause nd vomiting flowing abdor iin Cae tr rile informed Helene Pociee Wi the Carn ‘ay novation Research Instat Carin Unveiy of Tocholoy, PEWAlMle alain vostamncirinaddau/ nese Stevind WA 6 wwwonesthesa-nalgesia.org nnone,2.= some, 3 = alot, 4 = severe. Both scales are ordinal and use 4-point values from none to severe. In the current study, the same scale was used for all patients across all {reatments. Thus, for purposes ofthis study, itis suggested that the measurement instrument used has Sufficient valid- ity to provide consistently stable results. Future studies should address the issue of cross study instrument validity. Given the observed potential for aromatherapy blend deg radation, further studies should address more rigorously the differential effectiveness of ginger alone in comparison with the aromatherapy blend in the treatment of PON. Finally, the protocol deviation affected only 2 subjects, and the PP and ITT analyses both supported the study concli- sions, None of these limitations detracts appreciably from. the strength of the study results, which clearly suggest the potential and value of additional examination of aroma- therapies for treatment of PON, Further research should examine (1) aromatherapy and ‘vomiting, (2) the length of time aromatherapy is effective in treating PON with continued use, 3) a follow-up trial of different aromatherapies as treatment for PON (ginger versus the blend), (4) a larger study with standardized antiemetic medication treatment before and after surgery with stratified risk factor groups, and (5) a prevention trial in which aromatherapy is used prophylactically before surgery. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed. 8 DISCLOSURES: Name: Ronald Hunt, MD. Contribution: Ronald Hunt has seen the original study data, reviewed the analysis of the data, and approved the final smanuseript. Conflicts of Interest: In the planning and design of this researc, the goal has been, and is, to examine more carefully ‘whether specific aromas as therapeutic agents have differential results with patients in actual hospital PON situations. At the time that the study was designed, data were collected and analyzed, and the results discussed and written up, none of the fauthors had any conilict of interest. No conflict of interest ‘exists at this time. The procedure and results are reported so that medical personnel in other settings can replicate the study and obtain independent findings that will add evidence for the therapeutic uses of aromas. None of the authors at any time attempted to influence or predetermine the findings reported inthis article. There ae no monetary or other benefits to any of the authors from the research reported in this article. Analysis ofthe results of the statistical test procedures revealed the need for addtional research on treatment variations, and anecdotal evidence collected from research nurses and subjects sug- were no treatment delivery mechanisms that research proven, inexpensive, simple to use, and easly available. As a result, some experimental treatment delivery options that will require additional research have been ‘developed subsequent tothe data collection and analysis written up in this article, It too early to know with aay certainty ‘Whether these experimental procedures will produce monetary oF colher gain to any ofthe authors. The authors are committed £2 ‘igorous sclentifie research on treatment options and outcomes that can be independently verified and are uncontaminated by the possibilty of secondary gains or benefit. ANESTHESIA & ANALGESIA Copyright © 2042 international Anesthesia Research Society. Unauthorized reproduction ofthis article is prohibited.Name: Jacqueline Dienemann, PAD, RN. Contribution: Jacqueline Dienemann has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study fle, Conflicts of Interest: The author has no conflict of interest to declare ‘Name: H. James Norton, PhD. Contribution: H. James Norton reviewed the analysis of the data and approved the final manuscript. Conflicts of Interest: The author has no conflict of interest to declare ‘Name: Wendy Hartley, MSN, RN. Contribution: Wendy Hartley approved the final manuscript. Conflicts of Interest: The author has no conflict of interest to declare, Name: Amanda Hudgens, BSN, RN. Contribution: Amanda Hudgens approved the final manuscript. Conflicts of Interest: The author has no conflict of interest to declare, Name: Thomas Stern, MD. Contribution: Thomas Stern reviewed and edited the article and approved the final manuscript. Conflicts of Interest: The author has no conflict of interest to declare, ‘Name: George Divine, PRD. Contribution: George Divine reviewed the analysis ofthe data and approved the final manuscript Conflicts of Interest: The author has no conflict of interest to declare, ‘This manuscript was handled by: Peter S. A. MB, ChB. ACKNOWLEDGMENTS ‘We would like to thank Jo Ann DiFedele, LMBT, Dip AT, for developing, formulating, and supplying the aromatherapy ‘essential oils used in the study. In-kind funding was pro- vvided by Carolinas Medical Center University Department of Nursing, REFERENCES 1. Maman ME, Windle PE, Burkard JE. 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